NCT00878345

Brief Summary

The investigators believe dexmedetomidine will provide superior sedation with reduced side effects and reduced time to discharge compared with pentobarbital. The investigators have developed sedation protocols with pentobarbital and dexmedetomidine in our ambulatory procedure center. These protocols are both routinely used for sedation in our unit. The investigators propose to study these two protocols in children ages 6 months to 6 years presenting to the ambulatory procedure center for non-painful procedural sedation. The investigators will compare failure of sedation, side effect profile, recovery and discharge times between the two pharmacologic protocols.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

April 7, 2009

Last Update Submit

June 26, 2018

Conditions

Sedation

Keywords

Pediatric sedationPentobarbitalDexmedetomidineProcedural sedation in children

Outcome Measures

Primary Outcomes (1)

  • failure of sedation

    day of sedation

Secondary Outcomes (2)

  • side effect profile

    48 hours

  • post-sedation recovery and discharge time

    day of sedation

Study Arms (2)

1

ACTIVE COMPARATOR

Dexmedetomidine sedation protocol

Drug: dexmedetomidine sedation protocol

2

ACTIVE COMPARATOR

Pentobarbital sedation protocol

Drug: pentobarbital sedation protocol

Interventions

dexmedetomidine sedation protocolDRUG

Arm 1 will undergo sedation with dexmedetomidine, using 2 mcg/kg load IV over 10 minutes followed by an IV infusion of 1 mcg/kg/hr. May use versed 0.5 mg/kg IV x 1 for incomplete sedation, followed by increase of dexmedetomidine infusion to 1.5 mcg/kg/hr. Infusion will run throughout non-painful procedure (most likely MRI).

Also known as: Precedex
1
pentobarbital sedation protocolDRUG

Pentobarbital Sedation Protocol IV: 2.5 mg/kg, followed by 1.25 mg/kg as needed x2. Maintenance: May give additional 1.25 mg/kg IV x 2 if needed. Max total dose of 200 mg pentobarbital throughout sedation. May give midazolam 0.05 mg/kg IV x 1 PRN agitation for rescue sedation.

Also known as: Nembutal
2

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Requiring sedation for non-painful procedures
  • Normal airway per exam

You may not qualify if:

  • Congenital syndromes with known difficult airways
  • Known difficult airway during past anesthesia or sedation experience
  • Parent/guardian refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • Mason KP, Zgleszewski SE, Prescilla R, Fontaine PJ, Zurakowski D. Hemodynamic effects of dexmedetomidine sedation for CT imaging studies. Paediatr Anaesth. 2008 May;18(5):393-402. doi: 10.1111/j.1460-9592.2008.02451.x. Epub 2008 Mar 18.

    PMID: 18363628BACKGROUND

  • Mukhtar AM, Obayah EM, Hassona AM. Preliminary experience with dexmedetomidine in pediatric anesthesia. Anesth Analg. 2006 Jul;103(1):250. doi: 10.1213/01.ANE.0000228303.92422.73. No abstract available.

    PMID: 16790665BACKGROUND

  • Koroglu A, Teksan H, Sagir O, Yucel A, Toprak HI, Ersoy OM. A comparison of the sedative, hemodynamic, and respiratory effects of dexmedetomidine and propofol in children undergoing magnetic resonance imaging. Anesth Analg. 2006 Jul;103(1):63-7, table of contents. doi: 10.1213/01.ANE.0000219592.82598.AA.

    PMID: 16790627BACKGROUND

MeSH Terms

Interventions

DexmedetomidinePentobarbital

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBarbituratesPyrimidinonesPyrimidines
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

US(1)